Obligations associated with participation in a clinical trial

Adherence to study procedures

It is the responsibility of each clinical trial participant to read the Patient Information and agree to participate in the study by signing the Informed Consent Form. The aforementioned documents should contain a detailed description of all planned activities related to the study, i.e. study visits and protocol procedures. By agreeing to participate in the study, the subject will be deemed to have complied with all obligations arising from participation in the study and will voluntarily submit to the scheduled procedures and regular attendance at site visits.

Obligations as a result of taking the study drug

The participant should be instructed by the investigator as to how to take the study drug, dosage, and timing. Typically, the subject will be given a diary in which he or she should meticulously note the times and amounts of medication taken. It is absolutely forbidden to pass the study drug to other people. The participant is required to return the container each time along with any remaining unused medication.

Adherence to study restrictions

At times, participation in the study involves adherence to lifestyle restrictions. The participant, while agreeing to participate in the study, must scrupulously adhere to the restrictions usually associated with:

  • smoking
  • participating in sports
  • dietary restrictions

Restrictions on concomitant treatment

In most clinical trials there are restrictions on taking other drugs and dietary supplements. The treating physician is required to tell the subject which medications they can take concurrently during the study, and which they would have to stop taking. The same restrictions apply to all dietary supplements and herbal preparations for which potential interactions with the study drug are unknown. The decision to discontinue any drug or dietary supplement should be up to the investigator. At the same time, the investigator will be able to determine whether the potential discontinuation of currently used drugs does not outweigh the risk-benefit ratio of participation in the study.

Duty to report adverse events

It is the responsibility of the entire study team to inform the subject of their obligation to report adverse events.

An adverse event is any event that occurs during the course of participation in a clinical trial, whether caused by a drug or by other reasons. Such an event should be reported immediately to anyone on the study team, and it is advisable to contact the principal investigator when away from the site.

Contraception

Because of the unknown effects of the study drug on the fetus, as well as on fertility and other reproductive functions, an obligation to use an effective method of contraception has been assumed in clinical trials. This obligation applies not only to the clinical trial participant, but also to his/her partner/partner. Acceptable methods of contraception are usually defined by the protocol and the investigator should be consulted about which methods to use.

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